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Care coordinator facilitates the assessment and treatment of cancer-related symptoms

Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated

Collaborative care intervention to manage cancer-related symptoms

Collaborative Care

Enhanced usual Care

Jennifer L Steel, Ph.D.

The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma

Center for Epidemiological Studies-Depression scale

Functional Assessment of Cancer Therapy-Fatigue

National Cancer Institute (NCI)

University of Pittsburgh

Director, Center for Excellence in Behavioral Medicine

Behaviors and Mental Disorders

Depression

Anxiety Disorders

Depressive Disorder

Behavioral Symptoms

Mood Disorders

Mental Disorders

Psychotic Disorders

All patients seen in the UNC Bone Marrow Transplant clinic who are candidates for allogeneic transplantation attending their pre-admission visit were approached to offer study participation. Study participation included completion of surveys over a time period up to 60 days after their transplant.

Eliza M Park, MD

The primary purpose of this study is twofold: (1) to assess the feasibility of screening adult hematopoietic stem cell transplantation (HSCT) candidates for psychiatric comorbidity (depression and anxiety), and (2) to assess the feasibility of treating depression and anxiety in adult HSCT candidates through a collaborative care algorithm. The ultimate goal of this project is improving HSCT outcomes for allogeneic HSCT candidates by improving identification and treatment of depression and anxiety disorders.

Enrollment and depression and anxiety symptom screening:

All patients who are candidates for allogeneic transplantation and have a scheduled "Pre-Admission Visit" at UNC will be screened by study team to assess if they are eligible for participation. At their "Pre-Admission Visit" patients will be approached for enrollment in the study. Patients who provide written informed consent will complete the Hospital Anxiety and Depression Scale (HADS) survey at that time. If patients screen positive on the HADS (meaning a score of 8 or greater in the anxiety or the depression sections), they will be offered treatment within a collaborative care model intervention. If patients score less than 8 on the HADS survey (negative for symptoms of anxiety or depression) at the Pre-Admission Visit, they will not be offered treatment on study. Their medical records will still be abstracted periodically to follow post-transplant outcomes.

The Collaborative Care Model:

The collaborative care model is a team-delivered treatment program and will be provided by a treatment team of HSCT advanced practice providers (APP), HSCT physician, Comprehensive Cancer Support Program (CCSP) clinicians, and a psychiatrist. The collaborative care treatment intervention will be offered if patients score positive (score of 8 or greater) on the HADS. The collaborative care intervention includes medication consideration, therapy evaluation, and referral to psychiatry if needed.

Treatment Options in the Collaborative Care Model:

There will be three treatment options in the collaborative care model that will be offered to patients who score 8 or greater on the HADS - pharmacologic therapy, non-pharmacologic therapy, or both. If a patient chooses to start pharmacologic therapy after discussion with the APP at the Pre-Admission Visit, this treatment will include one of two antidepressants, which are standard-of-care treatments in medicine. The nonpharmacologic treatment in the Collaborative Care Model will involve a therapy consultation by the CCSP once patient is admitted to the hospital for their HSCT. Patients can also opt to take part in therapy with CCSP as well as taking medications.

The study team at the time of enrollment will gather patient demographics and clinical information including gender, age, disease type, donor HLA match, and history of mental health disorders from the medical record.

Follow-up HADS Surveys:

On Day 0, (day of stem cell infusion) to the hospital for HSCT, patients will undergo another HADS survey, and this will be repeated at Day +14 (+/- 3 days), Day +30 (+/- 3 days), and Day +60 (+/- 3 days). Information will be gathered from the medical records on Day +14, Day +30, and Day +60 regarding symptoms of mucositis, inability to tolerate oral medications, development of hospital-acquired illnesses, ICU admissions, reactivation of viruses (i.e. CMV), readmission to hospital, engraftment status, development of GVHD, and missed clinic appointments.

During the course of the study, all cases will be reviewed weekly in meetings with the psychiatrist and HSCT APPs to address mood symptoms, evaluate the need for titration of medications, and evaluate the need for psychotherapy, provided by CCSP therapist or psychiatrist.

Satisfaction Surveys:

At six months from initial patient enrollment, satisfaction surveys will be distributed to the HSCT APPs and HSCT physicians who have taken part in the study. Each patient at the end of study will also complete a satisfaction survey.

Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population

Assess the feasibility of systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale in adult patients who are allogeneic HSCT candidates.

Assess the feasibility of implementing a collaborative care model through assessment of intervention satisfaction scores among participating patients and their health care providers.

Explore an association between an investigator-designed post-transplant outcome index (listed below) in patients undergoing allogeneic transplantation and Hospital Anxiety and Depression Scale scores. Aggregated outcomes abstracted from the medical record included: (a) number of days spent in hospital during transplant admission, (b) number of missed clinic appointments, (c) development of acute GVHD, (d) development of chronic GVHD, (e) admission to ICU within first 100 days of transplant, (f) date of neutrophil engraftment, (g) frequency of viral reactivation requiring antiviral treatment, and (h) death in the first 100 days.

Explore whether patient's symptoms of depression and/or anxiety change over time within a collaborative care model.

UNC Lineberger Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms	NCT01640522	Hepatocellular ... Primary Liver C... Bile Duct Cance... Pancreatic Canc... Gallbladder Can... Colorectal Carc... Liver Metastase...	Collaborative C... Enhanced usual ...	18 Years -	University of Pittsburgh
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms	NCT01640522	Hepatocellular ... Primary Liver C... Bile Duct Cance... Pancreatic Canc... Gallbladder Can... Colorectal Carc... Liver Metastase...	Collaborative C... Enhanced usual ...	18 Years -	University of Pittsburgh
Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population	NCT04025190	Anxiety Depression		18 Years -	UNC Lineberger Comprehensive Cancer Center
Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population	NCT04025190	Anxiety Depression		18 Years -	UNC Lineberger Comprehensive Cancer Center

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